Stand Up To Cancer Hails FDA Approval of ALPELISIB + FULVESTRANT Combination For Patients With A PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer - Stand Up To Cancer


Posted June 11, 2019

Stand Up To Cancer Hails FDA Approval of ALPELISIB + FULVESTRANT Combination For Patients With A PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer

Stand Up To Cancer PI3K Women’s Cancers Dream Team Research Contributed to Approval Ruling is the 6th FDA Approval Supported by SU2C Research

(New York) June 11, 2019 – Stand Up To Cancer (SU2C) welcomed the recent Food and Drug Administration (FDA) approval of alpelisib in combination with fulvestrant, the first and only new therapy for a difficult to treat form of advanced or metastatic breast cancer in both post-menopausal women and in men. Research by one of SU2C’s inaugural Dream Teams, the SU2C PI3K Dream Team: “Targeting The PI3K Pathway In Women’s Cancers” contributed to the development of this treatment.

“This is the sixth FDA approval for a new cancer therapy supported by SU2C research,” said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, and Institute professor, David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology. “It’s compelling to see how SU2C’s innovative concept of collaborative, translational research is fulfilling our mission, to move fundamental insights to new effective treatments to save lives.”

One of five inaugural Dream Teams, this investigator-initiated grant was announced in May 2009, just months after the first SU2C telecast and exactly one year after SU2C was launched.

“This therapy will no doubt impact the lives of many women and men who have had no other effective therapy for advanced or metastatic HR+/HER2- breast cancer characterized by a PIK3CA mutation,” said Sung Poblete, PhD, RN, president and CEO of SU2C. “The Dream Team investigated the role of PI3K signaling in the development of resistance to hormone therapy in HR+ breast cancers which contributed to this approval. The team also successfully ran a Phase 1b trial combining PI3K inhibition with hormone therapy showing it was a safe therapeutic combination and had clinical benefit.”

Approximately 40 percent of HR+ advanced breast cancer patients have a mutation that may activate the PI3K-alpha isoform, called PIK3CA mutations. These mutations are associated with resistance to endocrine therapy, disease progression and a poor prognosis.

“Stand Up To Cancer Team support provided a unique opportunity for experts from eight institutions to come together and apply our varied expertise to this complex issue of addressing the role of the PI3K pathway mutations and pathway activation across women’s cancers. Many of us continue to pursue research and clinical trials extending from the work initiated by the original Dream Team, yielding additional, compelling findings and adding to the collective impact of this collaboration,” said Gordon B. Mills, MD, PhD, director of Precision Oncology, Knight Cancer Center, OHSU, co-leader of the SU2C PI3K Dream Team, and researcher noted for discoveries in the PI3K pathway in breast cancer. “This is truly a turning point in the management of this disease for so many breast cancer patients and we are proud to have played a role in the development of this effective treatment.”

The Dream Team engaged more than 60 researchers from University of Texas, MD Anderson Cancer Center; Beth Israel Deaconess Medical Center; Vanderbilt University; Massachusetts General Hospital; Columbia University Herbert Irving Comprehensive Cancer Center; Dana-Farber Cancer Institute; Memorial Sloan Kettering Cancer Center, and Vall d’Hebron Institute of Oncology.

The FDA announced the approval of alpelisib (Piqray®, Novartis) in combination with fulvestrant (Faslodex®, Astra Zeneca) for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer. This marks the first treatment specifically for a HR+/HER2- breast cancer with a PI3K mutation, which will allow for physicians to test for this mutation and design a treatment plan based on the result, according to Novartis. Concurrent with the approval of alpelisib, the therascreen® PIK3CA companion diagnostic test from QIAGEN was also approved by the FDA and is now available for patient testing.

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About Stand Up To Cancer
Stand Up To Cancer® (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization, was established in 2008 by film and media leaders who utilize the industry’s resources to engage the public in supporting a new, collaborative model of cancer research, and to increase awareness about cancer prevention as well as progress being made in the fight against the disease. Under the direction of our Scientific Advisory Committee, led by Nobel laureate Phillip A. Sharp, Ph.D., SU2C operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs.

Current members of the SU2C Council of Founders and Advisors (CFA) include Katie Couric, Sherry Lansing, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, Ellen Ziffren, and Kathleen Lobb. The late Laura Ziskin and the late Noreen Fraser are also co-founders. Sung Poblete, PhD, RN, has served as SU2C’s president and CEO since 2011.

For more information on Stand Up To Cancer, visit

Media Contacts:
Stand Up To Cancer
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